Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jul 31, 2027 | Orphan Designation: Treatment of diffuse large B-cell lymphoma Approved Labeled Indication: MONJUVI is indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT) Exclusivity Protected Indication: indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT) |
tagraxofusp-erzs (Injection) (Intravenous) Elzonris
NDA Applicant: Stemline Therapeutics, Inc. BLA No.: 761116 Prod. No.: 001 Rx (1,000MCG/1ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 21, 2025 | Orphan Designation: Treatment of blastic plasmacytoid dendritic cell neoplasm Approved Labeled Indication: ELZONRIS is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. Exclusivity Protected Indication: ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. |
Talimogene laherparepvec (For Injection) (Intralesional) Imlygic
NDA Applicant: Amgen Inc. BLA No.: 125518 Prod. No.: 001 Rx (100 MILLION PFU/ML); 002 Rx (1 MILLION PFU/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 27, 2022 | Orphan Designation: Treatment of stage IIb-stage IV melanoma Approved Labeled Indication: Indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery Exclusivity Protected Indication: Indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery |
tbo-filgrastim (Injection) (Subcutaneous) Granix
NDA Applicant: UAB Teva Baltics BLA No.: 125294 Prod. No.: 001 Rx (300MCG/0.5ML); 002 Rx (480MCG/0.8ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Ref. Product Exclusivity | Aug 29, 2024 |
tebentafusp-tebn (Injection) (Intravenous) Kimmtrak
NDA Applicant: Immunocore Limited BLA No.: 761228 Prod. No.: 001 Rx (100MCG/0.5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jan 25, 2029 | Orphan Designation: Treatment of uveal melanoma Approved Labeled Indication: treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma Exclusivity Protected Indication: treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma |
teclistamab-cqyv (Injection) (Subcutaneous) Tecvayli
NDA Applicant: Janssen Biotech, Inc. BLA No.: 761291 Prod. No.: 001 Rx (30MG/3ML (10MG/ML)); 002 Rx (153MG/1.7ML (90MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 25, 2029 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody |
teprotumumab-trbw (For Injection) (Intravenous) Tepezza
NDA Applicant: Horizon Therapeutics Ireland DAC BLA No.: 761143 Prod. No.: 001 Rx (500MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jan 21, 2027 | Orphan Designation: Treatment of active thyroid eye disease Approved Labeled Indication: TEPEZZA is indicated for the treatment of Thyroid Eye Disease. Exclusivity Protected Indication: For the treatment of active Thyroid Eye Disease |
thyrotropin alfa (For Injection) (Intramuscular) Thyrogen
NDA Applicant: Genzyme Corporation BLA No.: 020898 Prod. No.: 001 Rx (0.9MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 30, 2005 | Orphan Designation: As an adjunct in the diagnosis of thyroid cancer. Approved Labeled Indication: As an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with thyroid cancer. |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 14, 2014 | Orphan Designation: Treatment of well-differentiated papillary, follicular or combined papillary/follicular carcinomas of the thyroid Approved Labeled Indication: For use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of metastatic thyroid cancer |
tisagenlecleucel (Injection) (Intravenous) Kymriah
NDA Applicant: Novartis Pharmaceuticals Corporation BLA No.: 125646 Prod. No.: 001 Rx (0.6 to 6.0 x 10^8 CAR-POSITIVE VIABLE T CELLS)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 1, 2025 | Orphan Designation: Treatment of diffuse large B-cell lymphoma Approved Labeled Indication: KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma Exclusivity Protected Indication: For treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma after two or more lines of systemic therapy. |
| Exclusivity Type: Orphan Drug Exclusivity | May 27, 2029 | Orphan Designation: Treatment of follicular lymphoma Approved Labeled Indication: Treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy |
tocilizumab (; Injection) (; Intravenous) Actemra
NDA Applicant: Genentech, Inc. BLA No.: 125276 Prod. No.: 002 Rx (200MG/10ML (20MG/ML)); 003 Rx (400MG/20ML (20MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7332289 Method of purifying protein Claim Types: Process Pat. Sub. Date(s): None | Aug 4, 2023 | |
| Pat. No. 7521052 Methods for treating interleukin-6 related diseases Claim Types: Method of use Pat. Sub. Date(s): None | Apr 28, 2024 | |
| Pat. No. 8398980 Subtypes of humanized antibody against interleuken-6 receptor Claim Types: Compound; Composition Pat. Sub. Date(s): None | Sep 27, 2026 | |
| Pat. No. 8512983 Production of proteins in glutamine-free cell culture media Claim Types: Process; Cell culture medium Pat. Sub. Date(s): None | Jan 9, 2030 | |
| Pat. No. 8568720 High concentration antibody-containing liquid formulation Claim Types: Formulation Pat. Sub. Date(s): None | Nov 5, 2029 | |
| Pat. No. 8574869 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None | Jul 9, 2027 | |
| Pat. No. 8580264 Subcutaneously administered anti-IL-6 receptor antibody Claim Types: Method of use Pat. Sub. Date(s): None | Nov 8, 2030 | |
| Pat. No. 8617550 Treatment of vasculitis with IL-6 antagonist Claim Types: Method of use Pat. Sub. Date(s): None | Sep 11, 2025 | |
| Pat. No. 8709409 Method for treating rheumatoid arthritis by administering an anti-IL-6 antibody and methotrexate Claim Types: Method of use Pat. Sub. Date(s): None | Jun 22, 2024 | |
| Pat. No. 8734800 Subtypes of humanized antibody against interleukin-6 receptor Claim Types: Method of use Pat. Sub. Date(s): None | Mar 24, 2025 | |
| Pat. No. 9539263 Subcutaneously administered anti-IL-6 receptor antibody for treatment of systemic sclerosis Claim Types: Method of use Pat. Sub. Date(s): None | Nov 8, 2030 | |
| Pat. No. 9630988 Method for preparing a composition comprising highly concentrated antibodies by ultrafiltration Claim Types: Process Pat. Sub. Date(s): None | Jun 13, 2032 | |
| Pat. No. 9714293 Production of proteins in glutamine-free cell culture media Claim Types: Process Pat. Sub. Date(s): None | Jan 9, 2030 | |
| Pat. No. 9750752 Subcutaneously administered anti-IL-6 receptor antibody Claim Types: Method of use Pat. Sub. Date(s): None | Sep 1, 2031 | |
| Pat. No. 9902777 Methods for producing subtypes of humanized antibody against interleukin-6 receptor Claim Types: Process Pat. Sub. Date(s): None | May 28, 2025 | |
| Pat. No. 10017732 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None | Mar 15, 2033 | |
| Pat. No. 10231981 Subcutaneously administered anti-IL-6 receptor antibody for treatment of juvenile idiopathic arthritis Claim Types: Method of use Pat. Sub. Date(s): None | Nov 19, 2030 | |
| Pat. No. 10336983 Method for increasing the specific production rate of eukaryotic cells Claim Types: Process Pat. Sub. Date(s): None | Jul 31, 2035 | |
| Pat. No. 10501769 Method for the production of a glycosylated immunoglobulin Claim Types: Process Pat. Sub. Date(s): None | Oct 25, 2030 | |
| Pat. No. 10590164 Method for preparing a composition comprising highly concentrated antibodies by ultrafiltration Claim Types: Process Pat. Sub. Date(s): None | Mar 19, 2032 | |
| Pat. No. 10662237 Method to improve virus filtration capacity Claim Types: Process Pat. Sub. Date(s): None | May 26, 2030 | |
| Pat. No. 10676710 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None | Mar 15, 2033 | |
| Pat. No. 10744201 Method for treating rheumatoid arthritis with a human IL-6 receptor antibody and methotrexate Claim Types: Method of improving a treatment Pat. Sub. Date(s): None | Apr 28, 2024 | |
| Pat. No. 10829732 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None | Mar 15, 2033 | |
| Pat. No. 10874677 Subcutaneously administered anti-IL-6 receptor antibody Claim Types: Device Pat. Sub. Date(s): None | Mar 4, 2031 | |
| Pat. No. 10982003 Production of proteins in glutamine-free cell culture media Claim Types: Process Pat. Sub. Date(s): None | Aug 11, 2029 | |
| Pat. No. 11008394 High concentration antibody-containing liquid formulation Claim Types: Process Pat. Sub. Date(s): None | Dec 26, 2028 | |
| Pat. No. 11021728 Method for the production of a glycosylated immunoglobulin Claim Types: Formulation Pat. Sub. Date(s): None | Oct 25, 2030 | |
| Pat. No. 11078294 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None | Jul 9, 2027 | |
| Pat. No. 11136375 Method for production of antibody Claim Types: Process Pat. Sub. Date(s): None | Oct 14, 2028 | |
| Pat. No. 11136610 Method for the production of a glycosylated immunoglobulin Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): None | Oct 25, 2030 | |
| Pat. No. 11359026 High concentration antibody-containing liquid formulation Claim Types: Process Pat. Sub. Date(s): None | Dec 26, 2028 | |
| Pat. No. 11377678 Method for the production of a glycosylated immunoglobulin Claim Types: Process Pat. Sub. Date(s): None | Oct 25, 2030 | |
| Pat. No. 11584798 High concentration antibody-containing liquid formulation Claim Types: Formulation Pat. Sub. Date(s): None | Dec 26, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 29, 2020 | Orphan Designation: Treatment of pediatric patients (age 16 years and younger) with polyarticular-course juvenile idiopathic arthritis Approved Labeled Indication: ACTEMRA (tocilizumab) for subcutaneous injection is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older Exclusivity Protected Indication: Treatment of active polyarticular juvenile idiopathic arthritis in patients 2 through 16 years of age. |
| Exclusivity Type: Orphan Drug Exclusivity | Aug 30, 2024 | Orphan Designation: Treatment of chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome Approved Labeled Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older Exclusivity Protected Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 4, 2028 | Orphan Designation: Treatment of systemic sclerosis Approved Labeled Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease Exclusivity Protected Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease |
tocilizumab (Injection) (Subcutaneous) Actemra
NDA Applicant: Genentech, Inc. BLA No.: 125472 Prod. No.: 001 Rx (162MG/0.9ML); 002 Rx (162MG/0.9ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 29, 2020 | Orphan Designation: Treatment of pediatric patients (age 16 years and younger) with polyarticular-course juvenile idiopathic arthritis Approved Labeled Indication: ACTEMRA (tocilizumab) for subcutaneous injection is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older Exclusivity Protected Indication: Treatment of active polyarticular juvenile idiopathic arthritis in patients 2 through 16 years of age. |
| Exclusivity Type: Orphan Drug Exclusivity | Aug 30, 2024 | Orphan Designation: Treatment of chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome Approved Labeled Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older Exclusivity Protected Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 4, 2028 | Orphan Designation: Treatment of systemic sclerosis Approved Labeled Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease Exclusivity Protected Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease |
tositumomab and iodine I-131 tositumomab (Injection) (Intravenous) Bexxar
NDA Applicant: GlaxoSmithKline LLC BLA No.: 125011 Prod. No.: 001 Disc (35MG); 002 Disc (225MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 27, 2010 | Orphan Designation: Treatment of non-Hodgkin's B-cell lymphoma. Approved Labeled Indication: Treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy |
trastuzumab (For Injection) (Intravenous) Herceptin
NDA Applicant: Genentech, Inc. BLA No.: 103792 Prod. No.: 002 Rx (150MG) BLA No.: 103792 Prod. No.: 001 Disc (420MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8574869 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None | Jul 8, 2028 | |
| Pat. No. 10662237 Method to improve virus filtration capacity Claim Types: Process Pat. Sub. Date(s): None | May 26, 2030 | |
| Pat. No. 10808037 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None | Jul 8, 2028 | |
| Pat. No. 11078294 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None | Jul 8, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 20, 2017 | Orphan Designation: Treatment of HER2-overexpressing advanced adenocarcinoma of the stomach, including gastroesophageal junction Approved Labeled Indication: Treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease |
tremelimumab-actl (Injection) (Intravenous) Imjudo
NDA Applicant: AstraZeneca AB BLA No.: 761289 Prod. No.: 001 Rx (25MG/1.25ML (20MG/ML)); 002 Rx (300MG/15ML (20MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 21, 2029 | Orphan Designation: Treatment of hepatocellular carcinoma Approved Labeled Indication: In combination with durvalumab for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) Exclusivity Protected Indication: treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) |